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U.S. Department of Health and Human Services

Class 2 Device Recall Merge Unity Z3D software

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  Class 2 Device Recall Merge Unity Z3D software see related information
Date Initiated by Firm July 23, 2015
Create Date August 16, 2016
Recall Status1 Terminated 3 on October 07, 2016
Recall Number Z-2551-2016
Recall Event ID 74846
510(K)Number K041935  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge Unity Z3D software.

Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
Code Information Version 11.0
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact
262-367-0700
Manufacturer Reason
for Recall		 The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
FDA Determined
Cause 2		 Software design
Action The firm, Merge, sent a "canned" email on 7/23/2015 to its customers which also contained a personal message. The recalling firm issued a second letter entitled "URGENT: MEDICAL DEVICE RECALL" dated 1/27/2016 via e-mail on 1/30/2016. The letters described the product, problem and actions to be taken. The letter informed customers that an upgrade is available. The customers were instructed to call Merge Customer Service at (877) 741-5369 or send an email to support@merge.com to schedule the upgrade-Reference this recall #2016-14. If you decide to decline this maintenance release, complete the attached form and return to Merge Healthcare via recall@merge.com. Alternatively, complete the online form: http://www.merge.com/Landing-Pages/Customer-Upgrade-Decline-Form.aspx no later than February 22, 2016. Ensure that all users of the product are provided with this notification. If you have further distributed this, identify your customers and notify them at once of this product recall and provide a copy of the recall notification letter. If you have any additional questions, call Merge Customer Service at (877) 741-5369 or support@merge.com.
Quantity in Commerce 9 sites potentially have the affected version
Distribution US Distribution to states of: CA, PA, TX, and MT.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = DR. SYSTEMS, INC.
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